Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·C-65 DAILY CONTACT LENS CLEANER

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER MICROSOFT(TM) PTCA CATHETERS

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·PALACOS R BONE CEMENT

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-E AFP

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval

FDA Class 2 ·MINI BALLOON

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI GRUNTZIG DILACA CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·GAS PERMEABLE COMFORTCARE(TM)WETTING/SOAKING SOLUT

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT KERATOCONUS METHAFILCON B

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CIBA OPAQUE(TEFILICON)(HYDROPHILIC) CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS TRASKAR 18 PTCA DILITATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX FLOWTRACK (TM) 40 CORO. DILITATION CATH.

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SIMULVUE (HEFILCON A) BIFOCAL CONTACT LENS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·POLYQUAT DISINFECTION SYSTEM